Translucent smokeless tobacco product

ABSTRACT

A smokeless tobacco product is provided that includes a tobacco material in the form of a tobacco extract, a particulate tobacco material, or a combination thereof. In some embodiments, the smokeless tobacco product is substantially translucent. Methods for making and using the smokeless tobacco product are also provided. The smokeless tobacco product can include isomalt, maltitol syrup, particulate tobacco, and a translucent tobacco extract prepared by ultrafiltration.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/614,673, filed Sep. 13, 2012, which is acontinuation-in-part of U.S. patent application Ser. No. 13/240,525,filed Sep. 22, 2011. Both applications are hereby incorporated byreference in their entireties.

FIELD OF THE INVENTION

The present invention relates to products made or derived from tobacco,or that otherwise incorporate tobacco, and are intended for humanconsumption. In particular, the invention relates to smokeless tobaccoproducts containing ingredients or components obtained or derived fromplants of the Nicotiana species.

BACKGROUND OF THE INVENTION

Cigarettes, cigars and pipes are popular smoking articles that employtobacco in various forms. Such smoking articles are used by heating orburning tobacco, and aerosol (e.g., smoke) is inhaled by the smoker.Tobacco also may be enjoyed in a so-called “smokeless” form.Particularly popular smokeless tobacco products are employed byinserting some form of processed tobacco or tobacco-containingformulation into the mouth of the user. See for example, the types ofsmokeless tobacco formulations, ingredients, and processingmethodologies set forth in U.S. Pat. Nos. 1,376,586 to Schwartz;3,696,917 to Levi; 4,513,756 to Pittman et al.; 4,528,993 to Sensabaugh,Jr. et al.; 4,624,269 to Story et al.; 4,991,599 to Tibbetts; 4,987,907to Townsend; 5,092,352 to Sprinkle, III et al.; 5,387,416 to White etal.; 6,668,839 to Williams; 6,834,654 to Williams; 6,953,040 to Atchleyet al.; 7,032,601 to Atchley et al.; and 7,694,686 to Atchley et al.; USPat. Pub. Nos. 2004/0020503 to Williams; 2005/0115580 to Quinter et al.;2006/0191548 to Strickland et al.; 2007/0062549 to Holton, Jr. et al.;2007/0186941 to Holton, Jr. et al.; 2007/0186942 to Strickland et al.;2008/0029110 to Dube et al.; 2008/0029116 to Robinson et al.;2008/0173317 to Robinson et al.; 2008/0196730 to Engstrom et al.;2008/0209586 to Neilsen et al.; 2008/0305216 to Crawford et al.;2009/0065013 to Essen et al.; 2009/0293889 to Kumar et al.; 2010/0291245to Gao et al; and 2011/0139164 to Mua et al.; PCT WO 04/095959 to Arnarpet al. and WO 2010/132444 A2 to Atchley, each of which is incorporatedherein by reference. Exemplary smokeless tobacco products that have beenmarketed include those referred to as CAMEL Snus, CAMEL Orbs, CAMELStrips and CAMEL Sticks by R. J. Reynolds Tobacco Company; GRIZZLY moisttobacco, KODIAK moist tobacco, LEVI GARRETT loose tobacco and TAYLOR'SPRIDE loose tobacco by American Snuff Company, LLC; KAYAK moist snuffand CHATTANOOGA CHEW chewing tobacco by Swisher International, Inc.;REDMAN chewing tobacco by Pinkerton Tobacco Co. LP; COPENHAGEN moisttobacco, COPENHAGEN Pouches, SKOAL Bandits, SKOAL Pouches, RED SEAL longcut and REVEL Mint Tobacco Packs by U.S. Smokeless Tobacco Company; andMARLBORO Snus and Taboka by Philip Morris USA.

It would be desirable to provide an enjoyable form of a tobacco product,such as a smokeless tobacco product, and to provide processes forpreparing tobacco-containing compositions suitable for use in smokelesstobacco products.

SUMMARY OF THE INVENTION

The present invention provides a smokeless tobacco product comprisingtobacco or a derivative thereof obtained from plants of the Nicotianaspecies. The products of the invention are dissolvable compositionsadapted for oral consumption and exhibit a level of translucency despitecontaining a tobacco or tobacco-derived material. In certainembodiments, the products comprise a tobacco extract that can becharacterized as translucent or transparent.

In one aspect, the invention provides a smokeless tobacco productcomprising a tobacco material comprising a translucent tobacco extract;a sugar substitute in an amount of at least about 80% by weight of thesmokeless tobacco product; and a sugar alcohol syrup, wherein thesmokeless tobacco product is orally dissolvable and substantiallytranslucent. The amount and type of the sugar substitute can vary. Incertain embodiments, the sugar substitute is a non-hygroscopic sugaralcohol capable of forming a glassy matrix. For example, in someembodiments, the sugar substitute is isomalt. In certain embodiments,the sugar substitute is present in an amount of at least about 85% byweight or at least about 90% by weight. In some embodiments, the sugaralcohol syrup is maltitol syrup.

In one particular embodiment, invention provides a smokeless tobaccoproduct comprising: a tobacco extract in an amount of at least about 3%by weight; a sugar substitute in an amount of at least about 80% byweight; and a sugar alcohol syrup. In another embodiment, the smokelesstobacco product comprises at least about 1.0 percent by weight of thetranslucent tobacco extract, wherein the translucent tobacco extractconsists of components having a molecular weight of no more than about50,000 Da; a non-hygroscopic sugar alcohol capable of forming a glassymatrix in an amount of at least about 85% by weight; and a sugar alcoholsyrup in an amount sufficient to slow recrystallization of thenon-hygroscopic sugar alcohol. In yet another embodiment, the smokelesstobacco product comprises at least about 0.5 percent by weight of thetranslucent tobacco extract, wherein the translucent tobacco extractconsists of components having a molecular weight of no more than about50,000 Da; at least about 1.0 percent by weight of a particulate tobaccomaterial; a non-hygroscopic sugar alcohol capable of forming a glassymatrix in an amount of at least about 85% by weight; and a sugar alcoholsyrup in an amount sufficient to slow recrystallization of thenon-hygroscopic sugar alcohol. In a still further embodiment, theinvention provides a smokeless tobacco product comprising: a tobaccoextract consisting of components having a molecular weight of no morethan about 50,000 Da in an amount of at least about 3% by weight; anon-hygroscopic sugar alcohol capable of forming a glassy matrix in anamount of at least about 80% by weight; and a sugar alcohol syrup in anamount sufficient to slow recrystallization of the non-hygroscopic sugaralcohol.

In another aspect of the invention is provided a smokeless tobaccoproduct comprising: a first portion comprising at least about 80% byweight isomalt and a sugar alcohol syrup; and a second portioncomprising at least about 80% by weight isomalt and a sugar alcoholsyrup, wherein the two portions are visually distinguishable by color,and wherein at least one portion comprises a translucent tobaccoextract, such as a translucent tobacco extract in the form of an aqueousnicotine solution. The portions can, in some embodiments, comprisedifferent amounts of translucent tobacco extract and/or differentamounts of buffer. The portions can, in some embodiments, compriseflavorants in different types and/or amounts. The portions can, in someembodiments, comprise colorants in different types and/or amounts. Incertain embodiments, the first portion can comprise no added colorants.

The configuration of such multi-component products can vary. Forexample, in some embodiments, the second portion is completely encasedwithin the first portion and in some embodiments, both portions areexposed on the surface of the smokeless tobacco product. The ratio ofthe first portion to second portion can be, for example, between about1:20 and about 20:1 by volume or between about 1:10 and about 10:1 byvolume. In one specific embodiment, the first portion comprises isomalt,maltitol syrup, sodium chloride, vanillin, sucralose, citric acid,tobacco material comprising a translucent tobacco extract, andflavorant; and the second portion comprises isomalt, maltitol syrup,sodium chloride, vanillin, sucralose, citric acid, tobacco materialcomprising a translucent tobacco extract, flavorant, and a colorant. Incertain embodiments, one or both of the portions comprise one or more ofthe following: a flavorant in an amount from about 0.05 to about 15percent by weight of the smokeless tobacco product; sucralose in theamount from about 0.01 to about 2 percent by weight of the smokelesstobacco product; and sodium chloride in the amount from about 0.5 toabout 10 percent by weight of the smokeless tobacco product.

The form of the smokeless tobacco product can be, for example, a lozengewith a weight of between about 1.8 and about 2.2 g. The lozenge cancomprise, for example, between about 0.5 mg and about 5 mg nicotine. Insome embodiments, the lozenge comprises isomalt in an amount of at leastabout 90% by weight or at least about 95% by weight of the smokelesstobacco product.

The smokeless tobacco products described herein can optionally furtherinclude a throat irritation mitigant, such as sodium citrate, honey,ginger, pectin, capsaicin, camphor, dextromethorphan, echinacea, zincgluconate, peppermint oil, spearmint oil, eucalyptus oil, glycerin,organic acids, and combinations or extracts thereof.

The translucent tobacco extract used in the smokeless tobacco productsof the present disclosure can be characterized by the molecular weightof its components. For example, the translucent tobacco extract canconsist of compounds having a molecular weight of less than about 50,000Da., or compounds having a molecular weight of less than about 5,000 Da.The translucency of the tobacco extract can be characterized by apercent light transmittance (compared to water at 100% transmittance),such as a percent light transmittance of at least about 30% at visiblelight wavelengths greater than about 600 nm, or a percent lighttransmittance of at least about 40% at visible light wavelengths greaterthan about 600 nm, or a percent light transmittance of at least about50% at visible light wavelengths greater than about 600 nm (or evenhigher levels such as greater than about 60% or greater than about 70%or greater than about 80% at visible light wavelengths greater thanabout 600 nm).

In certain embodiments, the tobacco extract is an ultrafiltered tobaccoextract that can be characterized as translucent or transparent. Theextract can be, in some embodiments, a heat-treated tobacco extract thathas been treated prior to inclusion in the smokeless tobacco product byheating the tobacco extract in an aqueous solution comprising lysine,cysteine, asparaginase, or hydrogen peroxide. The aqueous solution cancomprise additional additives; for example, in some embodiments, theaqueous solution further comprises NaOH. In one exemplary embodiment, asmokeless tobacco product is provided, wherein the tobacco extract is aheat-treated tobacco extract that has been treated prior to inclusion inthe smokeless tobacco product by heating the tobacco extract in anaqueous solution comprising lysine and NaOH.

In certain embodiments, the tobacco material in the smokeless tobaccoproduct is a combination of a tobacco extract and particulate tobacco.The weight ratio of translucent tobacco extract to particulate tobaccois typically from about 5:1 to about 1:10 (e.g., about 2:1 to about 5:1or about 1:2 to about 1:6). In multi-component products, one or bothportions can optionally comprise a tobacco extract and particulatetobacco. In certain embodiments, the product can include a tobaccoextract in an amount of at least about 0.5 weight percent and aparticulate tobacco in an amount of at least about 1 weight percent.

The smokeless tobacco product can further comprise any one or moreadditional components. For example, in some embodiments, the smokelesstobacco product comprises one or more flavorants. The amount offlavorant can vary; for example, flavorant can be included in an amountof from about 0.1 to about 15 percent by weight of the smokeless tobaccoproduct. In certain embodiments, it can be included in an amount up toabout 2% or up to about 5% by weight of the smokeless tobacco product.The flavorant can be, in certain embodiments, vanillin and/or mintflavor. In some embodiments, the smokeless tobacco product furthercomprises at least one sweetener. One exemplary sweetener that can beused according to the invention is sucralose. In one embodiment, theproduct contains sucralose in the amount from about 0.01 to about 2percent by weight of the smokeless tobacco product. In some embodiments,the smokeless tobacco product further comprises sodium chloride (NaCl).The NaCl can be present in varying amounts; for example, in someembodiments, the amount of NaCl is from about 0.5 to about 10 percent byweight of the smokeless tobacco product. In certain embodiments, theamount of NaCl can be included in an amount of up to about 4% or up toabout 8% by weight of the smokeless tobacco product. The products canfurther optionally include a coating on at least a portion of theproduct.

In a further aspect of the invention, the invention provides a method ofpreparing a translucent smokeless tobacco product, comprising: mixing atranslucent tobacco extract, optionally a particulate tobacco, anon-hygroscopic sugar alcohol capable of forming a glassy matrix in amelted state, and a sugar alcohol syrup to form a mixture; and coolingthe mixture to room temperature to form a solid smokeless tobaccoproduct exhibiting translucency.

In another aspect is provided a method of preparing a translucentsmokeless tobacco product, comprising: mixing isomalt, and a sugaralcohol syrup to form a first mixture comprising at least about 80%isomalt by weight; separately mixing isomalt and a sugar alcohol syrupto form a second mixture comprising at least about 80% isomalt byweight; incorporating a translucent tobacco extract into one or both ofthe first and second mixtures; combining and cooling the mixtures toroom temperature to form a solid smokeless tobacco product with twoportions, wherein the two portions are visually distinguishable bycolor. The translucent tobacco extract can, in some embodiments, beincorporated into both the first and second mixtures. A colorant can beincorporated into at least one of the first and second mixtures, e.g., acolorant can be incorporated into both of the first and second mixturesin different amounts.

The translucent tobacco extract can, in some embodiments, be treatedprior to use in the methods disclosed herein. For example, the tobaccoextract can be treated by size exclusion chromatography,microfiltration, ultrafiltration, nanofiltration, reverse osmosis, or acombination thereof to produce the translucent tobacco extract. Incertain embodiments, the treatment removes components having a molecularweight above about 50,000 Da. In some embodiments, the treatment isconducted in combination with one or more additional treatments. Forexample, in some embodiments, the translucent tobacco extract issubjected to treatment with a non-imprinted polymer adapted for theremoval of tobacco-specific nitrosamines prior to use in the method.

In some embodiments, the translucent or transparent tobacco extract hasbeen heat treated prior to use in the method. For example, the tobaccoextract can be heated in an aqueous solution comprising lysine,cysteine, asparaginase, or hydrogen peroxide. In some embodiments, thetobacco extract is heated in such an aqueous solution, which can furthercomprise NaOH. In certain embodiments, the heat treating step isconducted at about 88° C. Using a heat treated tobacco extract can, insome embodiments, give a smokeless tobacco product having less thanabout 500 ppb acrylamide.

In some embodiments, the method of preparing a translucent smokelesstobacco product comprises heating the non-hygroscopic sugar alcohol to atemperature above the hard crack stage in the absence of the translucenttobacco extract and mixing the tobacco extract into the non-hygroscopicsugar alcohol at a temperature below the hard crack stage. Thetemperatures can vary; however, in certain embodiments, the hard crackstage is about 145° C. to about 155° C. and the non-hygroscopic sugaralcohol is heated at a temperature between the hard crack stage andabout 171° C. In some embodiments, the method further comprisesintroducing the mixture into a plurality of molds to create individualproduct units prior to the cooling step.

In another aspect of the invention, the invention provides a method ofpreparing a translucent or transparent extract for incorporating into asmokeless tobacco product, comprising: extracting a tobacco materialwith an aqueous solvent to form an aqueous tobacco extract;ultrafiltering the aqueous tobacco extract to remove components having amolecular weight above about 50,000 Da to form a translucent ortransparent tobacco extract; and heat treating the tobacco extract priorto or after the ultrafiltering step by heating the extract in an aqueoussolution comprising L-lysine, L-cysteine, asparaginase, or hydrogenperoxide. In certain embodiments, the ultrafiltering step comprisespassing the aqueous tobacco extract through multiple ultrafiltrationmembranes.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to provide an understanding of embodiments of the invention,reference is made to the appended drawings, which are exemplary only andshould not be construed as limiting the invention.

FIG. 1 graphically illustrates visible light transmission spectra of atobacco extract at various stages of processing according to theinvention; and

FIG. 2A-2H graphically illustrate various multi-component smokelesstobacco products provided according to the present disclosure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention now will be described more fully hereinafter. Thisinvention may, however, be embodied in many different forms and shouldnot be construed as limited to the embodiments set forth herein; rather,these embodiments are provided so that this disclosure will be thoroughand complete, and will fully convey the scope of the invention to thoseskilled in the art. As used in this specification and the claims, thesingular forms “a,” “an,” and “the” include plural referents unless thecontext clearly dictates otherwise. Reference to “dry weight percent” or“dry weight basis” refers to weight on the basis of dry ingredients(i.e., all ingredients except water).

The present invention relates to smokeless tobacco products adapted fororal consumption that contain tobacco or a tobacco-derived material andthat exhibit translucence or transparency, such as a product in the formof a translucent lozenge. The invention provides a process for preparinga tobacco material that can impart tobacco flavor to the product withoutreducing clarity of the product to the point of opacity, and a processfor preparing a translucent product using such a tobacco material.

The selection of the plant from the Nicotiana species utilized in theproducts and processes of the invention can vary; and in particular, thetypes of tobacco or tobaccos may vary. The type of tobacco used as boththe source of tobacco stalks and as the carrier for the syrup of theinvention can vary. Tobaccos that can be employed include flue-cured orVirginia (e.g., K326), burley, sun-cured (e.g., Indian Kurnool andOriental tobaccos, including Katerini, Prelip, Komotini, Xanthi andYambol tobaccos), Maryland, dark, dark-fired, dark air cured (e.g.,Passanda, Cubano, Jatin and Bezuki tobaccos), light air cured (e.g.,North Wisconsin and Galpao tobaccos), Indian air cured, Red Russian andRustica tobaccos, as well as various other rare or specialty tobaccos.Descriptions of various types of tobaccos, growing practices andharvesting practices are set forth in Tobacco Production, Chemistry andTechnology, Davis et al. (Eds.) (1999), which is incorporated herein byreference. Various representative types of plants from the Nicotianaspecies are set forth in Goodspeed, The Genus Nicotiana, (ChonicaBotanica) (1954); U.S. Pat. Nos. 4,660,577 to Sensabaugh, Jr. et al.;5,387,416 to White et al.; 7,025,066 to Lawson et al.; and 7,798,153 toLawrence, Jr.; and US Patent Appl. Pub. No. 2008/0245377 to Marshall etal.; each of which is incorporated herein by reference.

Exemplary Nicotiana species include N. tabacum, N. rustica, N. alata, N.arentsii, N. excelsior, N. forgetiana, N. glauca, N. glutinosa, N.gossei, N. kawakamii, N. knightiana, N. langsdorffi, N. otophora, N.setchelli, N. sylvestris, N. tomentosa, N. tomentosiformis, N. undulata,N. x sanderae, N. africana, N. amplexicaulis, N. benavidesii, N.bonariensis, N. debneyi, N. longiflora, N. maritina, N. megalosiphon, N.occidentalis, N. paniculata, N. plumbaginifolia, N. raimondii, N.rosulata, N. simulans, N. stocktonii, N. suaveolens, N. umbratica, N.velutina, N. wigandioides, N. acaulis, N. acuminata, N. attenuata, N.benthamiana, N. cavicola, N. clevelandii, N. cordifolia, N. corymbosa,N. fragrans, N. goodspeedii, N. linearis, N. miersii, N. nudicaulis, N.obtusifolia, N. occidentalis subsp. Hersperis, N. pauciflora, N.petunioides, N. quadrivalvis, N. repanda, N. rotundifolia, N.solanifolia and N. spegazzinii.

Nicotiana species can be derived using genetic modification orcrossbreeding techniques (e.g., tobacco plants can be geneticallyengineered or crossbred to increase or decrease production ofcomponents, characteristics or attributes). See, for example, the typesof genetic modifications of plants set forth in U.S. Pat. Nos. 5,539,093to Fitzmaurice et al.; 5,668,295 to Wahab et al.; 5,705,624 toFitzmaurice et al.; 5,844,119 to Weigl; 6,730,832 to Dominguez et al.;7,173,170 to Liu et al.; 7,208,659 to Colliver et al. and 7,230,160 toBenning et al.; US Patent Appl. Pub. No. 2006/0236434 to Conkling etal.; and 2008/0209586 to Nielsen et al., which are all incorporatedherein by reference.

For the preparation of smokeless tobacco products, it is typical forharvested plants of the Nicotiana species to be subjected to a curingprocess. Descriptions of various types of curing processes for varioustypes of tobaccos are set forth in Tobacco Production, Chemistry andTechnology, Davis et al. (Eds.) (1999). Exemplary techniques andconditions for curing flue-cured tobacco are set forth in Nestor et al.,Beitrage Tabakforsch. Int, 20, 467-475 (2003) and U.S. Pat. No.6,895,974 to Peele, which are incorporated herein by reference.Representative techniques and conditions for air curing tobacco are setforth in Roton et al., Beitrage Tabakforsch. Int., 21, 305-320 (2005)and Staaf et al., Beitrage Tabakforsch. Int., 21, 321-330 (2005), whichare incorporated herein by reference. Certain types of tobaccos can besubjected to alternative types of curing processes, such as fire curingor sun curing. Typically, harvested tobaccos that are cured are thenaged.

At least a portion of the plant of the Nicotiana species (e.g., at leasta portion of the tobacco portion) can be employed in an immature form.That is, the plant, or at least one portion of that plant, can beharvested before reaching a stage normally regarded as ripe or mature.As such, for example, tobacco can be harvested when the tobacco plant isat the point of a sprout, is commencing leaf formation, is commencingflowering, or the like. At least a portion of the plant of the Nicotianaspecies (e.g., at least a portion of the tobacco portion) can beemployed in a mature form. That is, the plant, or at least one portionof that plant, can be harvested when that plant (or plant portion)reaches a point that is traditionally viewed as being ripe, over-ripe ormature. As such, for example, through the use of tobacco harvestingtechniques conventionally employed by farmers, Oriental tobacco plantscan be harvested, burley tobacco plants can be harvested, or Virginiatobacco leaves can be harvested or primed by stalk position.

The Nicotiana species can be selected for the content of variouscompounds that are present therein. For example, plants can be selectedon the basis that those plants produce relatively high quantities of oneor more of the compounds desired to be isolated therefrom. In certainembodiments, plants of the Nicotiana species (e.g., Galpao communtobacco) are specifically grown for their abundance of leaf surfacecompounds. Tobacco plants can be grown in greenhouses, growth chambers,or outdoors in fields, or grown hydroponically.

Various parts or portions of the plant of the Nicotiana species can beemployed. For example, virtually all of the plant (e.g., the wholeplant) can be harvested, and employed as such. Alternatively, variousparts or pieces of the plant can be harvested or separated for furtheruse after harvest. For example, the flower, leaves, stem, stalk, roots,seeds, and various combinations thereof, can be isolated for further useor treatment.

The post-harvest processing of the plant or portion thereof can vary.After harvest, the plant, or portion thereof, can be used in a greenform (e.g., the plant or portion thereof can be used without beingsubjected to any curing process). For example, the plant or portionthereof can be used without being subjected to significant storage,handling or processing conditions. In certain situations, it isadvantageous for the plant or portion thereof be used virtuallyimmediately after harvest. Alternatively, for example, a plant orportion thereof in green form can be refrigerated or frozen for lateruse, freeze dried, subjected to irradiation, yellowed, dried, cured(e.g., using air drying techniques or techniques that employ applicationof heat), heated or cooked (e.g., roasted, fried or boiled), orotherwise subjected to storage or treatment for later use.

The harvested plant or portion thereof can be physically processed. Theplant or portion thereof can be separated into individual parts orpieces (e.g., the leaves can be removed from the stems, and/or the stemsand leaves can be removed from the stalk). The harvested plant orindividual parts or pieces can be further subdivided into parts orpieces (e.g., the leaves can be shredded, cut, comminuted, pulverized,milled or ground into pieces or parts that can be characterized asfiller-type pieces, granules, particulates or fine powders). The plant,or parts thereof, can be subjected to external forces or pressure (e.g.,by being pressed or subjected to roll treatment). When carrying out suchprocessing conditions, the plant or portion thereof can have a moisturecontent that approximates its natural moisture content (e.g., itsmoisture content immediately upon harvest), a moisture content achievedby adding moisture to the plant or portion thereof, or a moisturecontent that results from the drying of the plant or portion thereof.For example, powdered, pulverized, ground or milled pieces of plants orportions thereof can have moisture contents of less than about 25 weightpercent, often less than about 20 weight percent, and frequently lessthan about 15 weight percent.

The plant of the Nicotiana species or portions thereof can be subjectedto other types of processing conditions. For example, components can beseparated from one another, or otherwise fractionated into chemicalclasses or mixtures of individual compounds. Typical separationprocesses can include one or more process steps such as solventextraction using polar solvents, organic solvents, or supercriticalfluids, chromatography, distillation, filtration, recrystallization,and/or solvent-solvent partitioning. Exemplary extraction and separationsolvents or carriers include water, alcohols (e.g., methanol orethanol), hydrocarbons (e.g., heptane and hexane), diethyl ethermethylene chloride and supercritical carbon dioxide. Exemplarytechniques useful for extracting components from Nicotiana species aredescribed in U.S. Pat. Nos. 4,144,895 to Fiore; 4,150,677 to Osborne,Jr. et al.; 4,267,847 to Reid; 4,289,147 to Wildman et al.; 4,351,346 toBrummer et al.; 4,359,059 to Brummer et al.; 4,506,682 to Muller;4,589,428 to Keritsis; 4,605,016 to Soga et al.; 4,716,911 to Poulose etal.; 4,727,889 to Niven, Jr. et al.; 4,887,618 to Bernasek et al.;4,941,484 to Clapp et al.; 4,967,771 to Fagg et al.; 4,986,286 toRoberts et al.; 5,005,593 to Fagg et al.; 5,018,540 to Grubbs et al.;5,060,669 to White et al.; 5,065,775 to Fagg; 5,074,319 to White et al.;5,099,862 to White et al.; 5,121,757 to White et al.; 5,131,414 to Fagg;5,131,415 to Munoz et al.; 5,148,819 to Fagg; 5,197,494 to Kramer;5,230,354 to Smith et al.; 5,234,008 to Fagg; 5,243,999 to Smith;5,301,694 to Raymond et al.; 5,318,050 to Gonzalez-Parra et al.;5,343,879 to Teague; 5,360,022 to Newton; 5,435,325 to Clapp et al.;5,445,169 to Brinkley et al.; 6,131,584 to Lauterbach; 6,298,859 toKierulff et al.; 6,772,767 to Mua et al.; and 7,337,782 to Thompson, allof which are incorporated herein by reference. See also, the types ofseparation techniques set forth in Brandt et al., LC-GC Europe, p. 2-5(March, 2002) and Wellings, A Practical Handbook of Preparative HPLC(2006), which are incorporated herein by reference. In addition, theplant or portions thereof can be subjected to the types of treatmentsset forth in Ishikawa et al., Chem. Pharm. Bull., 50, 501-507 (2002);Tienpont et al., Anal. Bioanal. Chem., 373, 46-55 (2002); Ochiai,Gerstel Solutions Worldwide, 6, 17-19 (2006); Coleman, III, et al., J.Sci. Food and Agric., 84, 1223-1228 (2004); Coleman, III et al., J. Sci.Food and Agric., 85, 2645-2654 (2005); Pawliszyn, ed., Applications ofSolid Phase Microextraction, RSC Chromatography Monographs, (RoyalSociety of Chemistry, UK) (1999); Sahraoui et al., J. Chrom., 1210,229-233 (2008); and 5,301,694 to Raymond et al., which are allincorporated herein by reference.

According to the present invention, the Nicotiana plant or portionthereof is typically subjected to processing intended to provideimproved clarity of the tobacco material. In certain embodiments, thetobacco material used in the products of the invention is in the form ofan extract, such as an aqueous extract of a tobacco material. Improvedclarity of a tobacco extract can be obtained, for example, by removinghigh molecular weight components from the tobacco extract. In certainembodiments, high molecular weight components that are beneficiallyremoved according to the present invention include, but are not limitedto, high molecular weight Maillard browning polymers, proteins,polysaccharides, certain pigments, and bacteria. Various methods can beused for this purpose, including size exclusion chromatography,microfiltration, ultrafiltration, nanofiltration, reverse osmosis, andcombinations thereof.

In one embodiment, ultrafiltration is used to remove high molecularweight components in the tobacco material. The ultrafiltration method istypically applied to a tobacco material comprising a tobacco extract(e.g., an aqueous tobacco extract). In ultrafiltration, the material tobe filtered is brought into contact with a semipermeable membrane. Themembrane can be of any type, such as plate-and-frame (having a stack ofmembranes and support plates), spiral-wound (having consecutive layersof membrane and support material rolled up around a tube), tubular(having a membrane-defined core through which the feed flows and anouter, tubular housing where permeate is collected), or hollow fiber(having several small diameter tubes or fibers wherein the permeate iscollected in the cartridge area surrounding the fibers). The membranecan be constructed of various materials. For example, polysulfone,polyethersulfone, polypropylene, polyvinylidenefluoride, and celluloseacetate membranes are commonly used, although other materials can beused without departing from the invention described herein.

Ultrafiltration membranes are available in a wide range of pore sizes(typically ranging from about 0.1 to about 0.001 microns). Membranes aremore typically described by their molecular weight cutoffs.Ultrafiltration membranes are commonly classified as membranes withnumber average molecular weight cutoffs of from about 10³ Da to about10⁵ Da. In practice, compounds with molecular weights above themolecular weight cutoff are retained in the retentate, and the compoundswith molecular weights below the cutoff pass through the filter into thepermeate. Ultrafiltration methods typically are not capable of removinglow molecular weight organic compounds and ions.

Ultrafiltration is typically a cross-flow separation process. The liquidstream to be treated (feed) flows tangentially along the membranesurface, separating into one stream that passes through the membrane(permeate) and another that does not (retentate or concentrate). Theoperating parameters of the ultrafiltration system can be varied toachieve the desired result. For example, the feed mixture to be filteredcan be brought into contact with the membrane by way of appliedpressure. The rate of permeation across the membrane is directlyproportional to the applied pressure; however, the maximum pressure maybe limited. The flow velocity of the mixture across the membrane surfacecan be adjusted. Temperature can also be varied. Typically, permeationrates increase with increasing temperature.

Commercial ultrafiltration systems are readily available and may be usedfor the ultrafiltration methods of the present invention. For example,commercial suppliers such as Millipore, Spectrum® Labs, PallCorporation, Whatman®, Porex Corporation, and Snyder Filtrationmanufacture various filter membranes and cartridges, and/or filtrationsystems (e.g., tangential flow filtration systems). Exemplary membranesinclude, but are not limited to, Biomax® and Ultracel® membranes andPellicon® XL cassettes (from Millipore), Microkros®, Minikros®, andKrosFlo® Hollow Fiber Modules (from Spectrum® Labs), and Microza filtersand Centramate,™ Centrasette,™ Maximate™, and Maxisette™ Tangential FlowFiltration Membrane Cassettes. Commercially available filtration systemsinclude, but are not limited to, Millipore's Labscale™ Tangential FlowFiltration (TFF) system and Spectrum® Labs' KrosFlo® and MiniKros®Tangential Flow Filtration Systems.

Filters and/or membranes that may be useful according to the presentinvention include those with molecular weight cutoffs of less than about100,000 Da, less than about 75,000 Da, less than about 50,000, less thanabout 25,000 Da, less than about 20,000 Da, less than about 15,000 Da,less than about 10,000 Da, and less than about 5,000 Da. In certainembodiments, a multistage filtration process is used to provide anextract with improved clarity. Such embodiments employ multiple filtersand/or membranes of different (typically decreasing) molecular weightcutoffs. Any number of filters and/or membranes can be used insuccession according to the invention. For example, a first filtrationmay be conducted using a 50,000 Da molecular weight cutoff filter and asecond filtration may be conducted using a 5,000 Da molecular weightcutoff filter.

According to the present invention, the ultrafiltration process isdesigned to achieve a tobacco extract having a decreased level ofsuspended solids, and thus an increased level of clarity. For example,depending on the molecular weight cutoff of the filters, theultrafiltered extract may comprise only compounds with molecular weightsbelow about 50,000, below about 25,000, below about 10,000 Da, belowabout 7,500 Da, below about 5,000 Da, below about 2,500 Da, or belowabout 1,000 Da. The ultrafiltered extract typically comprises primarilysugars, nicotine, and amino acids.

The ultrafiltered extract exhibits a level of improvement in clarityover the non-ultrafiltered extract. Clarity of the extract, and tobaccoproducts according to the invention made therefrom, is typically definedin terms of translucency. As used herein, “translucent” or“translucency” refers to materials allowing some level of light totravel therethrough diffusely. In certain embodiments, certain materialsof the invention (e.g., certain tobacco extracts or final smokelesstobacco products made therefrom) can have such a high degree of claritythat the material can be classified as “transparent” or exhibiting“transparency,” which is defined as a material allowing light to passfreely through without significant diffusion. The clarity of theultrafiltered extract is such that there is some level of translucencyas opposed to opacity (which refers to materials that are impenetrableby light).

The improvement in clarity of the ultrafiltered extract over thenon-ultrafiltered extract can be quantified by any known method. Forexample, optical methods such as turbidimetry (or nephelometry) andcolorimetry may be used to quantify the cloudiness (light scattering)and the color (light absorption), respectively, of the ultrafilteredextract or products made therefrom. Translucency can also be confirmedby visual inspection by simply holding the material (e.g., extract) orproduct up to a light source and determining if light travels throughthe material or product in a diffuse manner.

In certain embodiments, the ultrafiltered extract is analyzed bycontacting the extract with light and measuring the percent of lightthat has not been absorbed and/or dispersed by the extract. Themeasurement can be done, for example, using a standard spectrophotometerat a given wavelength. The spectrophotometer is typically calibratedwith deionized water, which is assigned a transparency value of 100%.Acceptable levels of translucency/transparency at a given wavelength inthe ultrafiltered extract can vary. Typically, the extract of theinvention has a translucency (measured as percent light transmittance)of greater than about 5%, greater than about 10%, greater than about15%, greater than about 20%, greater than about 25%, greater than about30%, greater than about 40%, greater than about 50%, greater than about60%, greater than about 60%, greater than about 70%, greater than about80%, or greater than about 90%. One or more of these transparency levelsis typically achieved in certain embodiments, for example, at visiblelight wavelengths above about 400 nm (e.g., at a wavelength of about 500nm to about 700 nm such as about 500 nm, about 550 nm, about 600 nm,about 650 nm, and about 700 nm). Typically, the ultrafiltered extractwill not be colorless, and will have some discernible brown/blackcoloring. Following ultrafiltration, the extract can be stored in therefrigerator or freezer or the extract can be freeze dried or spraydried prior to use in the products of the invention. In certainembodiments, it is provided in syrup form.

Although in some embodiments, the tobacco extract is used directly, itmay be desirable to heat treat the extract. This thermal treatment canbe conducted before the ultrafiltration, after the ultrafiltration, orboth before and after the ultrafiltration. For example, a tobaccomaterial can be thermally processed by mixing the tobacco material,water, and an additive selected from the group consisting of lysine,glycine, histidine, alanine, methionine, glutamic acid, aspartic acid,proline, phenylalanine, valine, arginine, di- and trivalent cations,asparaginase, saccharides, phenolic compounds, reducing agents,compounds having a free thiol group, oxidizing agents (e.g., hydrogenperoxide), oxidation catalysts, plant extracts, and combinationsthereof, to form a moist tobacco mixture; and heating the moist tobaccomixture at a temperature of at least about 60° C. to form a heat-treatedtobacco mixture. In one embodiment, the treated tobacco extract is heattreated in the presence of water, NaOH, and an additive (e.g., lysine)at about 88° C. for about 60 minutes. Such heat treatment can helpprevent acrylamide production resulting from reaction of asparagine withreducing sugars in tobacco materials and can provide some degree ofpasteurization. See, for example, US Pat. Pub. No. 2010/0300463 to Chenet al., which is incorporated herein by reference. In certainembodiments wherein a heat-treated tobacco extract is used in asmokeless tobacco product of the present invention, the product can becharacterized by very low acrylamide content. For example, in someembodiments, the smokeless tobacco product is characterized by anacrylamide content of less than about 500 ppb (ng/g), less than about400 ppb, less than about 300 ppb, less than about 200 ppb, or less thanabout 100 ppb.

In addition to asparaginase noted above, the tobacco extract could alsobe treated with other enzymes and/or probiotics to inhibit acrylamideformation or otherwise chemically alter the tobacco extract as discussedin U.S. patent application Ser. No. 13/444,272 to Marshall et al., filedon Apr. 11, 2012 and U.S. patent application Ser. No. 13/553,222 toMoldoveanu, filed on Jul. 19, 2012, which are incorporated herein byreference. As used herein, the term “probiotic” or “probioticmicroorganism” is intended to encompass all live microorganisms that maybe classified as probiotics by various sources. For example, the Foodand Agriculture Organization of the United Nations (FAO) definesprobiotics as “live microorganisms, which, when administered in adequateamounts, confer a health benefit on the host.” In some reports, suchhealth benefits can include, but are not limited to: colonization of theintestinal, respiratory, and/or urogenital tracts, cholesterolmetabolism, lactose metabolism, absorption of calcium, synthesis ofvitamins, reduction of yeast and vaginal infections, reduction ofdigestive problems (e.g., constipation and diarrheal diseases),production of natural antibiotics, lactic acid, enzymes, hydrogenperoxide, inhibition of pathogenic microorganisms by production ofantibiotic-like substances; and a decrease in pH. Although thetraditional definition of “probiotic” relates to human and animaldigestive organisms, this term has been applied in other contexts, suchas in the field of agriculture. Certain types of probiotics andcompositional ingredients that can be added include examples set forthin U.S. Pat. Nos. 8,097,245 to Harel et al.; 8,097,281 to Heim et al.;8,101,167 to Gueniche; and 8,101,170 to Plail et al., which are allincorporated herein by reference.

It is preferred that probiotics used according to the invention are“GRAS” (Generally Regarded as Safe), although non-GRAS probiotics can beused in certain embodiments. Probiotics are typically identified bytheir genus, species, and strain level. Certain recognized probioticgenera include bifidobacterium, lactobacillus, enterococcus,proionobacterium, bacillus, saccharomyces, and streptococcus. Manycommon probiotics are selected from lactobacillus species,bifidobacterium species, and streptococcus thermophilus.

Exemplary enzymes that can be used to treat the tobacco extract includeamylases (which catalyze the breakdown of starch into sugars) orproteases (which catalyze the hydrolysis of peptide bonds of proteins)or a combination thereof. Amylases can include α-amylase, β-amylase,γ-amylase, or a combination thereof. Proteases can include serineproteases, threonine proteases, cysteine proteases, asparatateproteases, metalloproteases, and glutamic acid proteases and certainexemplary proteases include, but are not limited to, protease bacilluslicheniformis, protease bacillus sp., protease Aspergillus oryzae,protease bacillus amyloliquefaciens, protease bacillus, and proteaseStreptomyces griseus, which can include commercially available enzymeproducts Alcalase™, Esperase™, Everlase™, Flavourzyme™, Neutrase™,Protamex™, Savinase™, and Substilisin A™ from Novozymes A/S. In certainembodiments, the enzyme is a polyphenol oxidase (PPO), an oxidase suchas a monophenol oxidase enzyme (tyrosinase), or an o-diphenol oxygenoxidoreductase enzyme (catechol oxidase). Another exemplary oxidase foruse according to the invention is laccase.

The tobacco extract can also be subjected to further treatment steps,such as treatment steps adapted to remove specific classes of compoundsfrom the tobacco extract. For example, in some embodiments, the tobaccoextract is brought into contact with an imprinted polymer ornon-imprinted polymer such as described, for example, in US Pat. Pub.Nos. 2007/0186940 to Bhattacharyya et al; 2011/0041859 to Rees et al.;and 2011/0159160 to Jonsson et al; and U.S. patent application Ser. No.13/111,330 to Byrd et al., filed May 19, 2011, all of which areincorporated herein by reference. Treatment with a molecularly imprintedpolymer (MIP) or non-imprinted polymer (NIP) can be used to removecertain components of the extract, such as tobacco-specific nitrosamines(TSNAs), including N′-nitrosonornicotine (NNN),(4-methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK),N′-nitrosoanatabine (NAT), and N′-nitrosoanabasine (NAB); polyaromatichydrocarbons (PAHs), including benz[a]anthracene, benzo[a]pyrene,benzo[b]fluoranthene, benzo[k]fluoranthene, chrysene,dibenz[a,h]anthracene, and indeno[1,2,3-cd]pyrene; or other Hoffmannanalytes. Still further, the tobacco extract could be treated with ionexchange materials having amine functionality, which can remove certainaldehydes and other compounds. See, for example, U.S. Pat. Nos.4,033,361 to Horsewell et al and 6,779,529 to Figlar et al., which areincorporated by reference herein.

Accordingly, “treated tobacco extract” as used herein refers to atobacco extract that has been treated in some way to remove highmolecular weight components and thereby improve clarity (e.g., anultrafiltered extract). The treated tobacco extract may or may not beheat-treated (or treated with a MIP, NIP, or other material adapted toremove certain components of the extract) as described herein. Incertain embodiments, the treated tobacco extract comprises nicotine in ahigh concentration. For example, in some embodiments, the tobaccoextract comprises highly purified nicotine, e.g., at least about 90%nicotine by dry weight, at least about 95% nicotine by dry weight, atleast about 98% nicotine by dry weight, at least about 99% nicotine bydry weight, or at least about 99.9% nicotine by dry weight. Accordingly,in some embodiments, the tobacco extract comprising highly purifiednicotine is referred to as a tobacco-derived nicotine-containingsolution. It is understood that such extracts comprising a highconcentration of nicotine can have varying concentrations of nicotine,depending on the water content thereof.

The treated tobacco extract is used in the production of smokelesstobacco products. Accordingly, the present invention providestranslucent or transparent smokeless tobacco products comprisingtobacco-derived material.

Exemplary smokeless tobacco products of the invention have the form of alozenge, tablet, microtab, or other tablet-type product. See, forexample, the types of nicotine-containing lozenges, lozengeformulations, lozenge formats and configurations, lozengecharacteristics and techniques for formulating or manufacturing lozengesset forth in U.S. Pat. Nos. 4,967,773 to Shaw; 5,110,605 to Acharya;5,733,574 to Dam; 6,280,761 to Santus; 6,676,959 to Andersson et al.;6,248,760 to Wilhelmsen; and 7,374,779; US Pat. Pub. Nos. 2001/0016593to Wilhelmsen; 2004/0101543 to Liu et al.; 2006/0120974 to Mcneight;2008/0020050 to Chau et al.; 2009/0081291 to Gin et al.; and2010/0004294 to Axelsson et al.; which are incorporated herein byreference. The amount of material contained within each piece (e.g.,each unit of lozenge type of product) can vary. For example, arepresentative unit for lozenge products generally weighs at least about100 mg, often at least about 200 mg, and frequently at least about 300mg; while the weight of a representative unit for such productsgenerally does not exceed about 1.5 g, often does not exceed about 1 g,and frequently does not exceed about 0.75 g.

The amount of treated tobacco extract within the overall composition canvary. The treated tobacco extract can be provided in varyingconcentrations, which can affect the amount of extract included in themixture. The amount of extract is at least about 0.5%, generally atleast about 1%, often at least about 1.5%, often at least about 2%,often at least about 2.5%, and frequently at least about 3% by weight ofthe product mixture. In certain embodiments, the amount of extract is atleast about 4%, at least about 5%, at least about 6%, or at least about7% by weight of the product mixture. The amount of treated tobaccoextract added to the product mixture is typically not more than about20%. Exemplary types of such products can incorporate about 3% byweight, about 4% by weight, about 4.5% by weight of the mixture, orabout 7.5% by weight of the mixture.

Although the treated tobacco extract can be used as the sole tobaccosource in products of the invention, in certain embodiments, the treatedtobacco extract can be combined with one or more additional tobaccomaterials (e.g., solid tobacco material, such as filler-type pieces,granules, or fine powders). For example, in some embodiments, asmokeless tobacco product is provided that comprises treated tobaccoextract and milled tobacco. The manner by which the tobacco material isprovided in a particulate form may vary. Typically, plant parts orpieces are comminuted, ground or pulverized into a particulate formusing equipment and techniques for grinding or milling such as hammermills, cutter heads, air control mills, or the like. The plant materialis relatively dry in form during grinding or milling. For example,tobacco parts or pieces can be ground or milled when the moisturecontent thereof is less than about 15 weight percent to less than about5 weight percent. The milled tobacco material is typically employed inthe form of parts or pieces that have an average particle size less thanabout 50 microns. In one embodiment, the average particle size of thetobacco particles may be less than or equal to about 25 microns. In lesspreferred embodiments, the smokeless tobacco products contain a solidparticulate material as the sole tobacco material in the product (i.e.,in the absence of translucent tobacco extract).

The additional tobacco materials can be included in various amounts; forexample, in certain embodiments, the additional tobacco materials areincluded in an amount of between about 0.25% and about 10% by weight(e.g., between about 0.5% and about 6% by weight) based on the overallweight of the smokeless tobacco product. Where the smokeless tobaccoproduct comprises multiple sources of tobacco (i.e., treated tobaccoextract and one or more additional tobacco materials), the ratio oftreated tobacco extract to additional tobacco material can vary. Incertain embodiments, the weight ratio of treated tobacco extract tosolid tobacco (e.g., milled tobacco) is from about 5:1 to about 1:10(e.g., about 2:1 to about 5:1 or about 1:2 to about 1:6). In certainembodiments, the additional tobacco material is present in an amount ofat least about 1 weight percent or at least about 2 weight percent or atleast about 3 weight percent or more. In one particular embodiment, theproduct contains about 0.5 to about 5% by weight of treated tobaccoextract (e.g., about 0.5 to about 1.5% by weight or about 1% by weight)and about 1 to about 10% by weight (e.g., about 3 to about 7% by weightor about 5% by weight) milled tobacco.

In such embodiments, it is to be understood that only a portion of thesmokeless tobacco product may be completely transparent or translucentsince the presence of a solid tobacco particulate will create discreteareas within the product that are not translucent or transparent.Nonetheless, the inclusion level of such solid tobacco components istypically at a level low enough that the product can be viewed assubstantially translucent, meaning the product as a whole is translucentexcept for those portions of the product where the solid, opaquematerial is located. In embodiments comprising additional tobacco insolid form, the smokeless tobacco product may exhibit a transparent ortranslucent base with opaque portions therein (indicative of thepresence of the solid tobacco material). For example, where theadditional tobacco is provided in powdered, pulverized, granulated,ground, or milled form (i.e., a particulate form), it may be evidencedby dark specks or spots within a transparent or translucent product. Theopaque portions can be isolated to one or more regions of the product orcan be distributed throughout the product (e.g., uniformly distributed).The smokeless tobacco products can, in certain embodiments, be describedas substantially translucent or, stated differently, as comprising atleast about 50% by volume transparent or translucent material, at leastabout 60% transparent or translucent material, at least about 70%transparent or translucent material, at least about 80% transparent ortranslucent material, at least about 90% transparent or translucentmaterial, or at least about 95% transparent or translucent material.

Although sucrose can be used in the preparation of the smokeless tobaccoproducts of the present invention, the smokeless tobacco products aretypically sugar-free products, comprising one or more sugar substitutes.“Sugar-free” as used herein is intended to include products having lessthan about 1/15th sugar by weight, or less than about 1/10th sugar byweight.

Accordingly, in one embodiment, the smokeless tobacco product comprisesa sugar substitute. The sugar substitute is typically provided in pure,solid form (e.g., granular or powdered form). In certain embodiments,the sugar substitute is dry, comprising a very low water content. Forexample, the sugar substitute can comprise less than about 5% water byweight, less than about 3% water by weight, less than about 2% water byweight, or less than about 1% water by weight.

The sugar substitute can be any sugarless material (i.e., sucrose-freematerial) and can be natural or synthetically produced. The sugarsubstitute used in the invention can be nutritive or non-nutritive. Forexample, the sugar substitute is commonly a sugar alcohol. Sugaralcohols that may be useful according to the present invention include,but are not limited to, erythritol, threitol, arabitol, xylitol,ribotol, mannitol, sorbitol, dulcitol, iditol, isomalt, maltitol,lactitol, polyglycitol, and mixtures thereof. For example, in certainembodiments, the sugar alcohol is selected from the group consisting oferythritol, sorbitol, and isomalt. The amount of sugar substitute in thesmokeless tobacco product mixture can vary, but is typically at leastabout 75%, at least about 80%, at least about 85%, or at least about 90%by weight of the mixture.

In certain embodiments, the sugar substitute is capable of forming aglassy matrix. The formation of a glassy matrix is commonlycharacterized by a translucent/transparent appearance. Typically, thesugar substitute is substantially non-hygroscopic. Non-hygroscopicmaterials typically do not absorb, adsorb, and/or retain a significantquantity of moisture from the air. For example, in some embodiments, thesugar substitute exhibits a weight gain of water of less than about 50%upon exposure to conditions of 25° C., 80% relative humidity for twoweeks. Typically, the sugar substitute exhibits a weight gain of lessthan about 30%, less than about 20%, less than about 10%, less thanabout 5%, less than about 2%, or less than about 1% upon exposure toconditions of 25° C., 80% relative humidity for two weeks.Non-hygroscopic materials can provide the benefit of reducing thetendency of the smokeless tobacco product to tackify upon exposure tohumidity.

In certain embodiments, the sugar substitute comprises one or more sugaralcohols. For example, in one embodiment, the sugar substitute isisomalt. Isomalt is a disaccharide that is typically made by enzymaticrearrangement of sucrose into isomaltulose, followed by hydrogenation togive an equimolar composition of 6-O-α-D-glucopyranosido-D-sorbitol(1,6-GPS) and 1-O-α-D-glucopyranosido-D-mannitol-dihydrate(1,1-GPM-dihydrate).

In addition to the treated extract and sugar substitute, the smokelesstobacco product of the present invention contains a syrup, e.g., a sugarsyrup or a sugar alcohol syrup. “Sugar alcohol syrup” as used herein isintended to refer to a thick solution of sugar alcohol in water, e.g.,having greater than about 40% solids, preferably having greater thanabout 50% solids, greater than about 60% solids, greater than about 70%solids, or greater than about 80% solids. Typically, the solid contentof the sugar alcohol syrup primarily comprises the named sugar alcohol(i.e., maltitol syrup typically comprises greater than about 80%,greater than about 85%, or greater than about 90% by weight maltitol ona dry basis). Sugar alcohol syrups are generally prepared by heating asolution of the sugar alcohol in water and cooling the mixture to give aviscous composition. The resulting syrup is typically characterized by arelatively high concentration of sugar alcohol and relatively highstability (i.e., the sugar alcohol typically does not crystallize fromsolution, e.g., at room temperature).

The syrup, e.g., sugar alcohol syrup, desirably is capable of affectingthe re-crystallization of a melted sugar substitute. One exemplary sugaralcohol syrup that is particularly useful according to the presentinvention is maltitol syrup. Other sugar alcohol syrups can be used,including, but not limited to, corn syrup, golden syrup, molasses,xylitol, mannitol, glycerol, erythritol, threitol, arabitol, ribitol,mannitol, sorbitol, dulcitol, iditol, isomalt, lactitol, andpolyglycitol syrups. Such sugar alcohol syrups can be prepared or can beobtained from commercial sources. For example, maltitol syrups arecommercially available from such suppliers as Corn Products SpecialtyIngredients. Although sugar alcohol syrups may be preferred, sugarsyrups can, in certain embodiments, be used in place of or incombination with the sugar alcohol syrup. For example, in someembodiments, corn syrup, golden syrup, and/or molasses can be used.

The amount of sugar alcohol syrup added to the smokeless tobacco productmixture is typically that amount required to slow recrystallization ofthe sugar substitute in melted form. One of skill in the art wouldunderstand the need to vary the amount of sugar alcohol syrup dependingon the composition of the remaining ingredients to ensure that therecrystallization is sufficiently slow to provide a material with thedesired characteristics (e.g., a desired level oftranslucency/transparency). Accordingly, the amount of sugar alcoholsyrup can vary, but typically ranges from about 0.1% to about 2%, oftenfrom about 0.5% to about 1.5%, and more often about 1% by weight of thesmokeless tobacco product mixture. In certain embodiments, the amount ofsugar alcohol syrup is higher, for example, up to about 2% by weight ofthe mixture, up to about 5% by weight of the mixture, up to about 10% byweight of the mixture, or up to about 20% by weight of the mixture

In certain embodiments, the smokeless tobacco product further comprisesa salt. The presence of a salt in the smokeless tobacco product may actto suppress bitterness and/or enhance sweetness. Any type of salt can beused. Common table salt (NaCl) is typically used according to thepresent invention, but other types of salts are intended to beencompassed as well. The amount of salt added may vary, but typicallyranges from 0% to about 8%, for example from about 0.5% to about 4% orfrom about 0.6% to about 2%, often around 1% by weight of the smokelesstobacco product. In some embodiments, a somewhat salty taste is adesirable feature of the smokeless tobacco product.

In some embodiments, the composition according to the invention alsocontains one or more buffering agents and/or pH adjusters (i.e., acidsor bases). In some embodiments, one or more buffering agents and/or pHadjusters are added to the mixture to ensure that the final smokelesstobacco product has a pH within a desirable range. Exemplary pH rangesin such smokeless tobacco products are generally from about 6-11, andoften about 7-10 (e.g., about 7 or about 8). In such embodiments, theamount of buffering agent and/or pH adjuster added to the smokelesstobacco product mixture is simply that amount required to bring theformulation to or keep the formulation at the desired pH. The amount ofbuffering agent and/or pH adjuster added to any given formulation can bereadily calculated by one skilled in the art and may comprise, forexample, about 0.5% to about 1% by weight of the mixture. It is notedthat in certain embodiments, a basic pH is not necessary in the productsof the present invention. Accordingly, certain products of the presentinvention have a pH of less than about 6 or less than about 5 (e.g.,from about 4 to about 6).

Various food-grade buffering agents are known and can be used to adjustthe pH of the products of the present invention. Suitable bufferingagents include those selected from the group consisting of acetates,glycinates, phosphates, glycerophosphates, citrates such as citrates ofalkaline metals, carbonates, hydrogen carbonates, and borates, andmixtures thereof. In certain embodiments, the buffering agent is anamino acid, as taught for example, in US Pat. Pub. No. 2008/0286341 toAndersson et al. and PCT Appl. No. WO2008/040371 to Andersson et al.,which are both incorporated herein by reference. As noted therein,various amino acids and salts thereof are useful for this purpose,including, but not limited to, arginine, asparagine, glutamic acid,glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine,phenylalanine, serine, threonine, valine, cysteic acid, N-glycylglycine,and ornithine. In certain embodiments, N-glycylglycine or L-lysine isadded as a buffering agent. In some embodiments, an amino acid bufferingagent is used in combination with another amino acid buffering agentand/or in combination with one or more non-amino acid buffering agents.In certain embodiments, the optional pH adjusting agent is a base (e.g.,NaOH). In certain embodiments, L-lysine and NaOH are added to thecompositions of the present invention.

Certain tobacco extracts, particularly those subjected to heattreatment, can be buffered using various buffering systems. For example,one representative buffering system is sodium tripolyphosphate, but itis understood that other suitable types of buffering agents (includingother phosphates) can be used. In certain embodiments, the buffer can beadded in the form of an aqueous solution. For example, in onerepresentative example, an aqueous buffer solution is added to a mixtureof isomalt and maltitol syrup upon melting (e.g., at greater than about175° C.). The resulting mixture is cooled (e.g., to less than about 140°C.) and other components, including the treated tobacco extract (or acombination of a treated tobacco extract and milled tobacco) are addedto the mixture. The mixture is further cooled and molded as described inmore detail previously. The pH of an exemplary sample prepared in thismanner, when tested for pH by placing a 5 g of that sample in 100 g ofwater, exhibits a pH of about 7.8. The amount of buffering agent addedcan vary, but is generally an amount sufficient to maintain the pHwithin one of the exemplary pH ranges noted above. For example, anaqueous buffer system can be provided by dissolving about 22 weightparts sodium tripolyphosphate in about 73 weight parts water; and thebuffer system can be added to a melted mixture of about 275 weight partsisomalt and about 3 weight parts of maltitol syrup. The buffered isomaltmixture is heated to about 177° C. and then cooled to about 138° C.; andthen a mixture of about 6 weight parts tobacco extract (or a combinationof tobacco extract and milled tobacco), about 12 weight parts water,about 0.12 weight parts sucralose and about 0.3 weight parts flavorpackage is added to the buffered isomalt mixture. After mixing theresulting formulation, the formulation can be poured into a mold andcooled.

In some embodiments, one or more additional sweeteners are added to thecompositions of the present invention. The one or more additionalsweeteners can comprise any natural or artificial sweetener, including,but not limited to, sugar or any of the sugar substitutes describedpreviously. In certain embodiments, the sweetener can include,glycyrrhizin, glycerol, inulin, lactitol, mabinlin, maltitol, mannitol,miraculin, monatin, monellin, osladin, pentadin, polydextrose, sorbitol,stevia, tagatose, thaumatin, acesulfame potassium, alitame, aspartame,cyclamate, dulcin, glucin, neotame, saccharin, sucralose, andcombinations thereof. In certain embodiments, the sweetener comprisessucralose(1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside).The amount of sweetener added can vary, but is typically that amountrequired for a sufficiently “sweet” taste. For example, sweetener can beadded to make the sweetness of the smokeless tobacco product comparableto that of sugar. In particular embodiments, sucralose is added in anamount of about 0.01% to about 2% by weight of the mixture, often in anamount of about 1% by weight of the mixture.

Various natural and/or artificial flavorants can also be added to thesmokeless tobacco products of the present invention, and the characterof these flavors can be described as, without limitation, fresh, sweet,herbal, confectionary, floral, fruity or spicy. Specific types offlavors include, but are not limited to, vanilla (e.g., vanillinoptionally in complexed form), coffee, chocolate, cream, mint,spearmint, menthol, peppermint, wintergreen, lavender, cardamon, nutmeg,cinnamon, clove, cascarilla, sandalwood, honey, jasmine, ginger, anise,sage, licorice, lemon, orange, apple, peach, lime, cherry, andstrawberry. See also, Leffingwill et al., Tobacco Flavoring for SmokingProducts, R. J. Reynolds Tobacco Company (1972), which is incorporatedherein by reference. Flavorings also can include components that areconsidered moistening, cooling or smoothening agents, such aseucalyptus. Flavorings can also include sensates, which can add a rangeof tactile, organoleptic properties to the smokeless tobacco products.For example, sensates can provide a warming, cooling, or tinglingsensation. These flavors may be provided neat (i.e., alone) or in acomposite (e.g., spearmint and menthol, or orange and cinnamon).Flavorants of this type can be present in an amount of from about 0.1%to about 15%, often between about 0.2% and about 1.5% by weight of theproduct mixture. In other embodiments, flavorants of this type can bepresent in an amount of from about 0.02% to about 15%, e.g., from about0.05% to about 10% by weight of the product mixture. In certainembodiments, the flavorant is present in any amount of at least about0.1% by weight or at least about 0.2% by weight of the mixture.

In certain embodiments, one or more substances are added to thesmokeless tobacco composition for the purpose of soothing throatirritation that may develop during use of the product. The throatirritation mitigant can include any substance capable of mitigating orsoothing irritation caused by the smokeless tobacco product, andexpressly includes counter-irritants, anesthetics, and demulcents.Examples of throat irritation mitigants include sodium citrate, honey,ginger, pectin, capsaicin, camphor, dextromethorphan, echinacea, zincgluconate, peppermint oil, spearmint oil, eucalyptus oil, glycerin,organic acids (e.g., citric acid, lactic acid, levulinic acid, orsuccinic acid), and combinations or extracts thereof (e.g., oleoresinginger). Organic acids function by shifting the pH of the product intothe acidic range, such as the pH range of about 3 to about 6.5.Typically, the organic acid is an organic acid containing at least onecarboxylic acid group (e.g., carboxylic acids, dicarboxylic acids, andtricarboxylic acids). The amount of throat irritation mitigant used inthe product can vary, but will be an amount sufficient to provide somedegree of relief for throat irritation (e.g., a decrease in scratchy,lumpy sensations in the throat, a decrease in pain upon swallowing, adecrease in hoarseness while speaking, or a decrease in coughing). Inexemplary embodiments, the throat irritation mitigant is present in anamount of at least about 1 weight percent, or at least about 2 weightpercent, or at least about 3 weight percent (e.g., about 1 to about 10weight percent).

Various other substances can be added to the compositions of the presentinvention. For example, excipients such as fillers or carriers foractive ingredients (e.g., calcium polycarbophil, microcrystallinecellulose, hydroxypropylcellulose, sodium carboxymethylcellulose,cornstarch, silicon dioxide, calcium carbonate, lactose, and starchesincluding potato starch, maize starch, etc.), thickeners, film formersand binders (e.g., hydroxypropyl cellulose, hydroxypropylmethylcellulose, acacia, sodium alginate, xanthan gum and gelatin),antiadherents (e.g., talc), glidants (e.g., colloidal silica),humectants (e.g., glycerin), preservatives and antioxidants (e.g.,sodium benzoate and ascorbyl palmitate), surfactants (e.g., polysorbate80), dyes or pigments (e.g., titanium dioxide or D&C Yellow No. 10), andlubricants or processing aids (e.g., calcium stearate or magnesiumstearate) are added to the compositions in certain embodiments.

It is well-known that nicotine is subject to oxidation and accordingly,it may be advantageous to incorporate one or more anti-oxidants, suchas, e.g., ascorbyl palmitate and/or sodium ascorbate, in a compositionaccording to the invention. The one or more anti-oxidants may be presentin a concentration of from about 0.05% w/w to about 0.3% w/w, such as,e.g., from about 0.1% w/w to about 0.25% w/w or from about 0.15% w/w toabout 0.2% w/w in the smokeless tobacco product mixture.

Certain products of the present invention also can have outer coatings(e.g., an outer coating can be composed of ingredients such as carnaubawax and/or pharmaceutically acceptable forms of shellacs, glazingcompositions and surface polish agents). Application of a coating can beaccomplished using techniques such as airless spraying, fluidized bedcoating, use of a coating pan, or the like. Materials for use as acoating can be polymeric in nature, such as cellulosic material (e.g.,cellulose butyrate phthalate, hydroxypropyl methylcellulose phthalate,and carboxymethyl ethylcellulose), and polymers and copolymers ofacrylic acid, methacrylic acid, and esters thereof. In some embodiments,the coating can be a glazing or anti-sticking substance such as, forexample, CAPOL 570C, which is available from Capol GmbH (Elmshorn,Germany).

Representative compositions according to the present invention can havevarious types of formats and configurations, and as a result, thecharacter, nature, behavior, consistency, shape, form, size and weightof the composition can vary. The shape of a representative compositioncan be generally spherical, cylindrical (e.g., ranging form the generalshape of a flattened disc to the general shape of a relatively long,slender stick), helical, obloid, square, rectangular, or the like; orthe composition can have the form of a bead, granular powder,crystalline powder, capsule, film, strip, gel, or the like. The shape ofthe composition can resemble a wide variety of pill, tablet, lozenge,capsule, and caplet types of products. The size and weight of thecomposition can also vary; for example, in certain particularembodiments, each smokeless tobacco product unit has a weight of betweenabout 1.5 g and about 2.5 g (e.g., between about 1.8 g and about 2.2 g,such as about 1.9 g). In some embodiments, such products can comprise aparticular amount of nicotine, e.g., between about 0.5 mg and about 5 mgnicotine (e.g., between about 1 mg and about 3 mg, such as about 2 mg).

In some embodiments, more than one lozenge formulation can be containedwithin the same smokeless tobacco product. For example, one portion orcomponent of a given product can comprise one type of formulation,whereas a second portion or component of that product can comprise asecond type of formulation. In some embodiments, the formulations may besubstantially similar, but may vary from each other by one or twoingredients. For example, a two-component smokeless tobacco product canbe provided wherein one component comprises tobacco extract and onecomponent lacks tobacco extract; wherein one component has differentflavorants than the other component; wherein one component is bufferedand the other component is unbuffered, or wherein one component hasdifferent ratios of ingredients than the other component. The ratios ofthe two components or portions of a multi-component product generallycan be, e.g., about 1:20 to about 20:1, about 1:10 to about 10:1, orabout 1:5 to about 5:1 by volume.

In one specific embodiment, a multi-component smokeless tobacco productis provided, comprising one component that is colored (i.e., to which acolorant has been added), and one component that is uncolored (i.e.,which contains no added colorant). In some embodiments, amulti-component smokeless tobacco product is provided, comprising onecomponent that is colored (i.e., to which a colorant such as a dye orpigment has been added), and one component that is differently colored(i.e., having an entirely different color/hue or having a lighter shade,tint or brightness of the same color). Colorant as used herein isintended to cover any substance capable of modifying the color of thematerial and includes, but is not limited to, dyes and pigments.

Various colorants are known and can be incorporated in one or morecomponents of the smokeless tobacco products described herein.Generally, water-soluble colorants are used in the smokeless tobaccoproducts. They can be provided and incorporated into the smokelesstobacco products in liquid, powder, gel, or paste forms. Such colorantsare preferably marketed as food-grade colorants. Certain colorants aresynthetically derived (“artificial”) and include, but are not limitedto, FD&C Certified Dyes in various colors (e.g., red, orange, yellow,green, blue, brown, and black with certain specific dyes including, butnot limited to, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1,FD&C Blue No. 2, FD&C Red No. 3, FD&C Red No. 40, FD&C Green No. 3,Erythrosine, Fast Green FCF, Ponceau 4R, Allura Red, Red 2G, Fast Red E,Carmoisine, Amaranth, Chocolate Brown HT, Quinoline Yellow, Tartrazine,Sunset Yellow, Brilliant Blue FCF, Patent Blue V, Indigo Carmine, BrownHT, Black PN, Green S, and blends thereof, including Egg Yellow, KesariB, Apple Green, Pea Green, Raspberry Red, Strawberry Red, ChocolateBrown Y, Chocolate Brown K1, Chocolate Brown FCF, Black CTB, Black NCTB,Black 1011, and mixtures thereof). Certain colorants are naturalcolorants and include, but are not limited to, caramel color/malt color,iron oxides, titanium dioxide, calcium carbonate, and color provided bysuch materials as red cabbage, paprika, safflower, elderberries,spinach, carrot, radish, purple sweet potato, black carrot, beets,turmeric, riboflavin, lutein, beta carotene/carotenoids, saffron,lycopene, chlorophyll, annatto, and mixtures thereof.

Although the present disclosure focuses on two-component products, it isnoted that additional colored and/or uncolored components can beincluded (e.g., a three-component, four-component, or five-componentproduct).

In certain embodiments, such multi-component smokeless tobacco productscan be described as having two or more portions that are visuallydistinguishable by color. This can mean, for example, that the two ormore portions exhibit different colors as determined by visualinspection by an unaided human eye in standard lighting conditions. Suchsmokeless tobacco products have two or more distinct regions that arevisibly distinct in appearance and readily distinguishable from oneanother. Typically, such products comprise two or more portions whereina given color is isolated within a particular geometric configuration(e.g., a spherical ball or “dot,” column, or irregularly shapedconfiguration). For example, in certain specific embodiments, oneportion is clear and one portion is green; one portion is clear and oneportion is amber; one portion is clear and one portion is blue, etc. Incertain specific embodiments, one portion is dark green and one portionis light green; one portion is dark amber and one portion is lightamber; one portion is dark blue and the other portion is light blue,etc. In further embodiments, one portion is green and one portion isblue; one portion is green and one portion is amber; one portion is blueand one portion is amber, etc. In still further embodiments, thedifference in color can be provided by a difference in translucency,e.g., wherein one portion is clear and one portion is translucent.

Where a discrete section of the smokeless tobacco product is colored,that discrete section can be, e.g., completely contained within anuncolored (or differently colored) section of the smokeless tobaccoproduct (e.g., as a colored spherical portion or “dot” within anotherwise uncolored (or differently colored) material). See, forexample, the embodiments illustrated in FIGS. 2A and 2E (single dotwithin colored and differently colored materials) and FIGS. 2B and 2F(two dots within colored and differently colored materials). Of course,such “dots” need not be spherical and can be, e.g., oval or irregularlyshaped. Although in the illustrated embodiments, the dots are present inthe interior (i.e., completely encased within the uncolored (ordifferently colored) component), in some embodiments, the dot can belocated within the product such that at least a portion of the dot isexposed on the surface of the smokeless tobacco product.

In some embodiments, the discrete colored section may comprise acolumn-type configuration, running from one edge of the smokelesstobacco product to the other end. See, for example, the embodimentsillustrated in FIGS. 2C and 2G (column within colored and differentlycolored material). In other embodiments, a larger portion of thediscrete colored section can be exposed on the surface of the smokelesstobacco product (e.g., as a colored half, side by side with an uncolored(or differently colored) half of the smokeless tobacco product). See,for example, the embodiments illustrated in FIGS. 2D and 2H. It is alsonoted that the colored and uncolored portions (or colored anddifferently colored portions) illustrated in FIG. 2 can be switched. Forexample, in the embodiments of FIGS. 2A, 2B, 2E, and 2F, the dots couldbe colorless or lighter in color as compared with the exteriorcomponent. Similarly, in the embodiments of FIGS. 1C and 1G, the columncould be colorless or lighter in color and the exterior component couldbe the colored portion. Of course, many more geometric configurationscomprising a colored portion and an uncolored portion and/or a coloredportion and a differently colored portion can be envisaged by one ofskill in the art.

The percentage of colored section within the smokeless tobacco productcan vary. For example, where the discrete colored section is completelycontained within an uncolored (or differently colored) section of thesmokeless tobacco product, the discrete colored section can comprise,for example, between about 5% and about 30% of the smokeless tobaccoproduct by weight. Where the discrete colored section comprises a largerportion of the product (e.g., as a colored portion in a side-by-sidetype structure or as a column running from one side of the product tothe other side of the product), the discrete colored section cancomprise between about 10% and about 90% of the smokeless tobaccoproduct by weight (e.g., between about 20% and about 80% of thesmokeless tobacco product).

Where a discrete section of the smokeless tobacco product is colored,the colored section can be otherwise identical in composition to theuncolored (or differently colored) section or it may vary in composition(e.g., it may have different types or amounts of flavorings than theuncolored (or differently colored) section). Both the colored anduncolored (or differently colored) sections can, in some embodiments,comprise treated tobacco extract; however, in some embodiments, one ormore sections within the smokeless tobacco product can comprise adifferent amount of treated tobacco extract than another section (e.g.,one or more sections may comprise no treated tobacco extract).

The manners and methods used to formulate and manufacture the smokelesstobacco product can vary. For example, the compositions can be preparedvia any method commonly used for the preparation of hard boiledconfections. Exemplary methods for the preparation of hard confectionscan be found, for example, in LFRA Ingredients Handbook, Sweeteners,Janet M. Dalzell, Ed., Leatherhead Food RA (December 1996), pp. 21-44,which is incorporated herein by reference.

Typically, a first mixture of ingredients is prepared. The compositionof the first mixture of ingredients can vary; however, it typicallycomprises a sugar substitute and may contain various additionalsubstances (e.g., the sugar alcohol syrup, NaCl, preservatives, furthersweeteners, water, and/or flavorings). In certain embodiments, itcomprises the sugar substitute, salt, and vanillin. In otherembodiments, the first mixture comprises the sugar substitute and thesugar alcohol syrup. Typically, the first mixture of ingredients doesnot contain the treated tobacco extract or other tobacco material.

The first mixture of ingredients is heated until it melts; subsequently,the mixture is heated to or past the hard crack stage. In confectionarymaking, the hard crack stage is defined as the temperature at whichthreads of the heated mixture (obtained by pulling a sample of cooledsyrup between the thumb and forefinger) are brittle or as thetemperature at which trying to mold the syrup results in cracking.According to the present method, the temperature at which the hard crackstage is achieved can vary, depending on the specific makeup of theproduct mixture but generally is between about 145° C. and about 170° C.Typically, the mixture is not heated above about 171° C., which is thetemperature at which caramelization begins to occur. In the processes ofthe present invention, the mixture is typically heated to the hard crackstage temperature or above and then allowed to cool. The heating can beconducted at atmospheric pressure or under vacuum. Typically, the methodof the present invention is conducted at atmospheric pressure.

In one exemplary embodiment, the first mixture of ingredients comprisesa high percentage of isomalt and the mixture is heated to about 143° C.Once all components are dissolved, the temperature is raised past thehard crack stage (e.g., to about 166° C.). The mixture is heated to thistemperature and then removed from the heat to allow the mixture to cool.

In certain embodiments, the treated tobacco extract and, optionally,additional components (e.g., additional tobacco materials, sweeteners,fillers, flavorants, and water) as described above are separatelycombined. The treated tobacco extract-containing mixture is added to thefirst mixture of ingredients, typically after the first mixture ofingredients has been removed from the heat. The addition of the treatedtobacco extract-containing mixture may, in some embodiments, occur onlyafter the heated first mixture of ingredients has cooled to apredetermined temperature (e.g., in certain embodiments, to about 132°C.). In certain embodiments, one or more flavorants are added to thetreated tobacco extract-containing mixture immediately prior to addingthe mixture to the first, heated mixture of ingredients. Certainflavorants are volatile and are thus preferably added after the mixturehas cooled somewhat.

The combined mixture is then formed into the desired shape. In certainembodiments, the mixture is poured directly into molds, formed (e.g.,rolled or pressed) into the desired shape, or extruded. If desired, themixture can be extruded or injection molded. In certain embodiments, themixture is formed or extruded into a mold of desired shape in anenclosed system, which may require decreased temperature and which maylimit evaporation of certain mixture components. For example, such asystem may limit the evaporation of volatile components including, butnot limited to, flavorants. Other methods of producing smokeless tobaccoproducts and/or lozenges are also intended to be encompassed herein.

Multi-component smokeless tobacco products can be produced according tothe methods described herein. In some embodiments, the colored and theuncolored (or differently colored) materials can be co-deposited at thesame time (i.e., using a “single pass” system). In some embodiments, thecolored and the uncolored (or differently colored) materials can bedeposited in different stages. For example, to prepare a smokelesstobacco product comprising a colored “dot” within an uncolored (ordifferently colored) matrix, the “dot” composition can be depositedfirst and then the uncolored or differently colored matrix compositioncan be subsequently deposited (i.e., using a “two pass” system).

Although the foregoing description has focused on treated tobaccoextract-containing smokeless tobacco products, it is noted that thecompositions and methods are intended to encompass other tobacco-derivedor non-tobacco derived smokeless tobacco products as well. For example,tobacco-derived or non-tobacco derived nicotine or a derivative thereofcan be used in the present invention. Representative nicotine-containingextracts can be provided using the techniques set forth in U.S. Pat. No.5,159,942 to Brinkley et al., which is incorporated herein by reference.Extracts containing relatively high nicotine content can be buffered,e.g., using buffering agents such as citric acid to lower the pH of theextracts. Reference to a tobacco extract (e.g., ultrafiltered ortranslucent tobacco extracts) herein is intended to encompass anytobacco-derived extract of varying purity with respect to componentsfound in tobacco, including highly purified nicotine-containing extractsproduced from tobacco material.

As mentioned above, nicotine may be present in any suitable form.Normally, nicotine is selected from the group consisting of nicotinebase, nicotine hydrochloride, nicotine dihydrochloride, nicotinemonotartrate, nicotine bitartrate, nicotine sulfate, nicotine zincchloride such as nicotine zinc chloride monohydrate and nicotinesalicylate. In some embodiments, nicotine is in its free base form,which can optionally be sorbed on a carrier (e.g., microcrystallinecellulose) for inclusion in a smokeless tobacco product. See, forexample, the nicotine/carrier compositions set forth in US Pat. Pub. No.2004/0191322 to Hansson, which is incorporated by reference herein.

Typical conditions associated with manufacture of food grade productssuch as described herein include control of heat and temperature (i.e.,the degree of heat to which the various ingredients are exposed duringmanufacture and the temperature of the manufacturing environment),moisture content (e.g., the degree of moisture present within individualingredients and within the final composition), humidity within themanufacturing environment, atmospheric control (e.g., nitrogenatmosphere), airflow experienced by the various ingredients during themanufacturing process, and other similar types of factors. Additionally,various process steps involved in product manufacture can involveselection of certain solvents and processing aids, use of heat andradiation, refrigeration and cryogenic conditions, ingredient mixingrates, and the like. The manufacturing conditions also can be controlleddue to selection of the form of various ingredients (e.g., solid,liquid, or gas), particle size or crystalline nature of ingredients ofsolid form, concentration of ingredients in liquid form, or the like.Ingredients can be processed into the desired composition by techniquessuch as extrusion, compression, spraying, and the like.

In certain embodiments, the smokeless tobacco product is transparent ortranslucent as defined herein. Transparency/translucency can bedetermined by any means commonly used in the art; however, it iscommonly measured by spectrophotometric light transmission over a rangeof wavelengths (e.g., from about 400-700 nm). Transmission measurementsfor the smokeless tobacco products of the present invention aretypically higher than those of traditional tobacco-extract containingsmokeless tobacco products. Translucency can also be confirmed by visualinspection by simply holding the smokeless tobacco product up to a lightsource and determining if light travels through the product in a diffusemanner.

Aspects of the present invention are more fully illustrated by thefollowing examples, which are set forth to illustrate certain aspects ofthe present invention and are not to be construed as limiting thereof.

EXPERIMENTAL Example 1 Ultrafiltration of Tobacco Extract

A tobacco extract is prepared by mixing hot water (140-155° C.) andtobacco at a ratio of 8:1 water:tobacco. The mixture is agitated for 1hour and is then centrifuged. The supernatant thus obtained isevaporated to ˜25% solids. The extract is centrifuged again (4000 rpmfor 10 min) in 50 mL conical tubes to remove any large particles thatremain. The supernatant is filtered using a vacuum filter system and 7μm filter paper.

The filtered supernatant is diluted 1:1 with distilled, deionized waterand placed in the reservoir of a Millipore Tangential Flow Filter (TFF)system. A first TFF system was fitted with a Pellicon Biomax-50 (MWCO50,000 Da) cartridge. A second TFF system was fitted with a PelliconBiomax-5 (MWCO 5,000 Da) cartridge. The permeate passing through thefirst TFF system is directed into the reservoir of the second TFFsystem. The resulting final permeate is collected in a clean beaker.This ultrafiltered extract is placed in a freezer at −80° C. overnight,and then removed and placed in a freeze dryer. The tray of the freezedryer was set to −20° C. and the vacuum was set at 0.600 mBar. Theextract is kept in the freeze dryer until dry, approximately 36-48hours.

Beginning with 600 mL of evaporated tobacco extract (˜25% solids), 50 gof freeze-dried material was obtained. Assuming 60% of the water wasevaporated from the initial tobacco material, the extract represented1500 mL (1500 g) of water that was exposed to 187.5 g tobacco (8:1water:tobacco ratio). Of that mass, 45% (84.4 g) is hot waterextractable. Of the hot water extractable material, 59% passed throughthe ultrafiltration freeze-drying process (i.e., 26.6% of the startingtobacco mass made it through the ultrafiltration freeze-drying process).

The ultrafiltered, freeze-dried extract has the consistency of lightbrown sugar, is highly hygroscopic, and has a pleasant/sweet aroma.Analysis shows that the extract contains sugars, organic acids, salts,alkaloids, and nicotine. In humid conditions, it forms a brown, viscous,translucent syrup. The ultrafiltered, freeze-dried extract has much lesscolor and more clarity than the initial tobacco extract.

Example 2 Preparation of Smokeless Tobacco Product (with No HeatTreatment)

Isomalt, NaCl, and vanillin are mixed in a pot and the temperature ofthe mixture is brought to 143° C. The mixture is held at 143° C. untilthe isomalt is melted and the temperature is then increased to 166° C.In a separate vessel, treated tobacco extract from Example 1, maltitolsyrup, H₂O, sucralose, and, optionally, L-lysine are mixed to forth asolution. Optionally, in a second separate vessel, water and sodiumhydroxide are mixed to form a solution.

The isomalt mixture is removed from the heat and allowed to cool to 132°C. The remaining components (i.e., the extract containing solution andoptional sodium hydroxide solution) are combined and, optionally, one ormore flavorings are added to the combined solution. The combinedsolution is poured into the hot isomalt mixture and folded in.

The resulting mixture is poured into molds to form smokeless tobaccoproducts. When the mixture becomes too viscous to pour, the mixture canbe heated in a microwave using high heat (e.g., for about 7 seconds).Representative smokeless tobacco product mixtures are set forth below.Mixture 1 below contains no base, while Mixtures 2 and 3 contain sodiumhydroxide at varying levels.

MIXTURE 1 Ingredient Percent by weight Isomalt ST-M* 90.37 Maltitolsyrup 1.00 Ultrafiltered tobacco 3.84 extract (77% solids) NaCl 1.00Vanillin 0.30 Sucralose 0.20 H₂O 3.16 Flavorant 0.13 Final pH = 4.5*Isomalt in which 1,6-GPS and 1,1-GPM are present in essentiallyequimolar amounts and which has a medium grain size, the diameter ofapproximately 90% of all particles being <3 mm.

MIXTURE 2 Ingredient Percent by weight Isomalt ST-M 90.37 Maltitol syrup1.00 Ultrafiltered tobacco 3.84 extract (77% solids) NaCl 1.00 Vanillin0.30 Sucralose 0.20 H₂O 3.01 Flavorant 0.13 NaOH 0.15 Final pH = 6.6

MIXTURE 3 Ingredient Percent by weight Isomalt ST-M 90.37 Maltitol syrup1.00 Ultrafiltered tobacco 3.84 extract (77% solids) NaCl 1.00 Vanillin0.30 Sucralose 0.20 H₂O 2.86 Flavorant 0.13 NaOH 0.30 Final pH = 8.1

Example 3 Preparation of Smokeless Tobacco Product (with Heat-TreatedTobacco Extract)

Certain smokeless tobacco products are prepared using tobacco extractthat has been heat treated with different additives to reduce the amountof acrylamide. A heat-treated tobacco extract is prepared by combiningan ultrafiltered tobacco extract prepared according to Example 1 with anadditive to reduce acrylamide in water and stirring until a solution isformed. The resulting mixture is heated to 88° C. and held at thistemperature for 60 minutes. The mixture is cooled and additional wateris added to return the mixture to the starting weight of 200 g.

Mixtures 4-7, described in the tables below, relate to smokeless tobaccoproducts comprising heat-treated tobacco extract prepared in this way.Part A outlines the components of the heat treatment process. Themixtures comprise different additives for the reduction of acrylamide.The resulting heat-treated tobacco extract can be stored frozen untiluse. This heat-treated tobacco extract is used in the preparation of asmokeless tobacco product according to the method provided above, usingthe components detailed in Part B of Mixtures 4-7.

As one specific example, heat-treated tobacco extract is prepared bycombining H₂O (65.79 g), treated tobacco extract, 77% solids (118.42 g),NaOH (8.90 g), and L-lysine (6.89 g), stirring until dissolved, heatingto 88° C., and holding at this temperature for 60 minutes. The mixtureis cooled to 29° C. and additional H₂O is added to return the mixture tothe starting weight of 200 g.

MIXTURE 4 Part A - Extract Treatment with NaOH and L-lysine IngredientGrams Ultrafiltered tobacco 118.42 extract (77% solids) H₂O 65.79 NaOH8.50 L-lysine 7.29 Part B - Preparation of Smokeless Tobacco ProductIngredient Percent by weight Isomalt ST-M 90.00 Maltitol syrup 1.00Heat-treated 7.60 tobacco extract NaCl 1.00 Vanillin 0.10 Sucralose 0.15Flavorant 0.15 Final pH = 7.76

MIXTURE 5 Part A - Extract Treatment with NaOH and L-cysteine 97%Ingredient Grams Ultrafiltered tobacco 118.42 extract (77% solids) H₂O65.79 NaOH 8.50 L-cysteine 97% 7.29 Part B - Preparation of SmokelessTobacco Product Ingredient Percent by weight Isomalt ST-M 90.00 Maltitolsyrup 1.00 Heat-treated 7.60 tobacco extract NaCl 1.00 Vanillin 0.10Sucralose 0.15 Flavorant 0.15 Final pH = 7.86

MIXTURE 6 Part A - Extract Treatment with NaOH and AsparaginaseIngredient Grams Ultrafiltered tobacco 118.42 extract (77% solids) H₂O65.79 NaOH 8.50 Asparaginase 1.50 Part B - Preparation of SmokelessTobacco Product Ingredient Percent by weight Isomalt ST-M 90.00 Maltitolsyrup 1.00 Heat-treated 7.60 tobacco extract NaCl 1.00 Vanillin 0.10Sucralose 0.15 Flavorant 0.15 Final pH = 8.29

MIXTURE 7 Part A - Extract Treatment with NaOH and 3% Hydrogen PeroxideIngredient Grams Ultrafiltered tobacco extract (77% solids) 118.42 NaOH50% solution 17.00 3% hydrogen peroxide solution 80.00 Part B -Preparation of Smokeless Tobacco Product Ingredient Percent by weightIsomalt ST-M 90.00 Maltitol syrup 1.00 Heat-treated tobacco extract 7.60NaCl 1.00 Vanillin 0.10 Sucralose 0.15 Flavorant 0.15 Final pH = 8.10

The compositions comprising heat-treated tobacco extract exhibitedrelatively low acrylamide levels in the final smokeless tobacco products(Mixture 4=343 ng/g, Mixture 5=44.8 ng/g, Mixture 6=190 ng/g, andMixture 7=445 ng/g). These acrylamide levels represent a significantdecrease as compared with tobacco extract that has not been heattreated. For example, heat treated tobacco extract can exhibit up toabout a 98% reduction in acrylamide level over non-heat-treated tobaccoextract. The values for smokeless tobacco products represented byMixtures 4-7 represent a reduction in acrylamide level of from about 60%to about 96% over a comparable smokeless tobacco product wherein thetobacco extract has not been heat treated.

Example 4 Preparation of Smokeless Tobacco Product Combining TobaccoExtract and Particulate Tobacco

Isomalt and maltitol syrup are mixed in a pot until the isomalt ismelted. In a separate vessel, treated tobacco extract prepared accordingto Example 1, H₂O, NaCl, sucralose, and flavorings are mixed to form asolution.

The isomalt mixture is removed from the heat and allowed to cool. Theextract-containing solution is poured into the hot isomalt mixture andfolded in. Optionally, milled tobacco is added, either to the isomaltmixture (prior to combining the isomalt mixture with theextract-containing solution, or to the combined mixture).

The resulting combined mixture is poured into molds to form smokelesstobacco products. When the mixture becomes too viscous to pour, themixture can be heated in a microwave using high heat (e.g., for about 7seconds). Representative smokeless tobacco product mixtures are setforth below as Mixtures 8-10.

MIXTURE 8 Ingredient Percent by weight Isomalt ST-M 92.16 Maltitol syrup1.00 Ultrafiltered tobacco 2.00 extract (77% solids) NaCl 0.70 Sucralose0.04 H₂O 4.00 Flavorant 0.10

MIXTURE 9 Ingredient Percent by weight Isomalt ST-M 87.55 Maltitol syrup0.95 Ultrafiltered tobacco 1.9 extract (77% solids) NaCl 0.66 Sucralose0.04 H₂O 3.8 Flavorant 0.10 Milled tobacco 5.0

MIXTURE 10 Ingredient Percent by weight Isomalt ST-M 91.24 Maltitolsyrup 0.99 Ultrafiltered tobacco 0.69 extract (77% solids) NaCl 3.96Sucralose 0.04 H₂O 3.96 Flavorant 0.10 Milled tobacco 1.0

Example 5 Preparation of Smokeless Tobacco Product Comprising ThroatIrritation Mitigant

a) Ginger as Throat Irritation Mitigant

Panelists are provided with a lozenge comprising 3% by weight tobaccoextract and 1.5% by weight ginger powder and a control lozengecomprising 3% by weight tobacco extract (without ginger). The controllozenge is sampled first, followed by the ginger-containing lozenge.Using a rating scale of 1-15, users note some degree of throatirritation associated with the control lozenge. Users note a decrease inboth peak mouth sensation intensity and peak throat sensation intensityand note an overall preference for the ginger-containing lozenge.

b) Sodium Citrate and Oleoresin Ginger as Throat Irritation Mitigant

Panelists are provided with a lozenge comprising 3% by weight tobaccoextract with 2% by weight sodium citrate and 0.35% by weight oleoresinginger and a control lozenge comprising 3% by weight tobacco extract(without sodium citrate or oleoresin ginger). The oleoresin ginger andsodium citrate-containing lozenge is sampled first, followed by thecontrol lozenge. Using a rating scale of 1-15, users note an increase inboth peak mouth sensation intensity and peak throat sensation intensityfor the oleoresin ginger and sodium citrate-containing lozenge. Becausethe oleoresin ginger and sodium citrate-containing lozenge was sampledfirst, this result may be due to an inability of the panelists todistinguish the differences between the samples. It is also possiblethat the oleoresin ginger, which inherently has a strong pepperysensation as well as an intense ginger flavor, successfully masks anythroat irritation caused by other components of the lozenge, but mayitself contribute to throat irritation at certain inclusion levels.

Example 6 Alternative Processing of Tobacco Extract with TSNA Removal

A tobacco extract is prepared as described in Example 1, except insteadof freeze drying, the liquid, ultrafiltered extract is passed through anon-imprinted polymer (NIP) cartridge available from Biotage LLC,Charlotte, N.C. to remove tobacco specific nitrosamines (TSNAs).Surprisingly, it is found that the NIP cartridge removes even more ofthe brown tobacco pigments remaining in the ultrafiltered extract,resulting in a significant increase in light transmission through theextract. The resulting treated extract is concentrated to about 20%solids and spray dried.

FIG. 1 shows the visible light transmission spectrum of the treatedtobacco extract processed according to this example to demonstrate colorremoval. A Hewlett Packard 8463 UV/Visible Spectrometer equipped withboth tungsten and deuterium lamps is used to gather the data. Samplesare measured neat (as-is) using a 1 cm path-length quartz cell. Water isused as a reference for 100% transmittance.

As illustrated, each step in the process resulted in higher levels oftransmittance for much of the visible light spectrum, which confirmsthat the process of the invention increases translucence of the extractand, by extension, translucence of products made using the extract. Fora wavelength of 600 nm (yellow to orange light), the amount of lighttransmitted approximately doubles after each step, going from ˜10%(extract prior to ultrafiltration) to ˜20% (after 50 kDaultrafiltration) to ˜40% (after 5 kDa ultrafiltration) to ˜80% (afterNIP cartridge).

Example 7 Alternative Processing of Tobacco Extract to InhibitAcrylamide Formation

The process of Example 1 is altered by adding 0.1 to about 0.5% byweight of asparaginase (available as PreventASe™ from DSM FoodSpecialties, Heerlen, N L or Acrylaway® from Novozymes, A/S, Bagsvaerd,DK) to the 8:1 water:tobacco slurry of Example 1 and maintaining thetemperature of the slurry at no more than about 60° C. or heating theslurry as indicated in Example 1 and thereafter cooling the slurry to nomore than about 60° C. before addition of the asparaginase. Followingthe enzyme treatment, the enzyme is optionally deactivated by raisingthe temperature of the slurry to at least about 70° C. for 30 minutes ormore.

The filtration steps of Example 1 are then performed. Theultrafiltration treatment steps remove the asparaginase sinceasparaginase has a molecular weight of about 50 kDa. The extract is thenconcentrated, such as by simple evaporation through heating, treatmentin a rotary evaporator under vacuum, reverse osmosis, or use of athin-film evaporator.

Example 8 Preparation of One-Component Smokeless Tobacco Product

A: Preparation of Smokeless Tobacco Product

Isomalt, maltitol syrup, and vanillin are combined to form a slurry.Separately, NaCl is mixed with water, and the resulting NaCl solution isadded to the slurry in a cooking vessel. The temperature of the isomaltmixture in the cooking vessel is brought to 350° F. (about 177° C.). Ina separate vessel, the nicotine solution, vanillin, sucralose, citricacid, sucralose, additional flavoring(s) and colorant(s) are mixed.

The isomalt mixture is allowed to cool to 300° F. (about 149° C.). Thenicotine solution-containing mixture is added to the hot isomalt mixtureand stirred for about 20 seconds or until well-blended. The resultingmixture is removed from the heat and transferred to a depositor. Fromthe depositor, the resulting mixture is deposited into molds to formsmokeless tobacco products (each product designed as a 1.0 gramweight/piece with approximately 2 mg nicotine). The smokeless tobaccoproducts are allowed to cool and set and then dispensed from the molds.A representative product mixture is set forth below.

PRODUCT MIXTURE Ingredient Percent by weight Isomalt ST-M 95.965Maltitol syrup 1.00 Tobacco extract* 1.40 NaCl 1.40 Vanillin 0.05Sucralose 0.01 Citric acid 0.05 H₂O 5.00 Flavorant 0.05 Colorant 0.075*The tobacco extract is in the form of a nicotine solution comprising7.5% nicotine and 93.5% water.

B: Coating of Smokeless Tobacco Product

Optionally, a coating can be applied to the smokeless tobacco product.CAPOL 570C, which is available from Capol GmbH (Elmshorn, Germany) canbe used as the coating material. The uncoated smokeless tobacco productsare weighed and this weight is used to calculate the amount of CAPOL570C to add. The uncoated products are stirred to evenly coat with theCAPOL 570C. An exemplary amount of coating added to the products isbased on the following table.

COATED PRODUCT Ingredient Percent by weight Uncoated smokeless tobaccoproduct 99.88 CAPOL 570C 0.20

Example 9 Preparation of Two-Component Smokeless Tobacco Product

A: Preparation of Amber Colored Core Component

Isomalt, maltitol syrup, and vanillin are combined to form a slurry.Separately, NaCl is mixed with water, and the resulting NaCl solution isadded to the slurry in a cooking vessel. The temperature of the isomaltmixture in the cooking vessel is brought to 350° F. (about 177° C.). Ina separate vessel, Nicotine solution, vanillin, sucralose, citric acid,sucralose, additional flavoring(s) and colorant(s) are mixed.

The isomalt mixture is allowed to cool to 300° F. (about 149° C.). Thenicotine solution-containing mixture is added to the hot isomalt mixtureand stirred for about 20 seconds or until well-blended. The resultingmixture is removed from the heat and transferred to a depositor. Arepresentative amber colored core component mixture is set forth below.

COLORED CORE COMPONENT MIXTURE Ingredient Percent by weight Isomalt ST-M95.14 Maltitol syrup 1.00 Tobacco extract* 1.40 NaCl 1.40 Vanillin 0.05Sucralose 0.01 Citric acid 0.05 H₂O 5.00 Flavorant 0.05 Colorant 0.90*The tobacco extract is in the form of a nicotine solution comprising7.5% nicotine and 93.5% water.

B: Preparation of Uncolored Outer Component

Isomalt, maltitol syrup, and vanillin are combined to form a slurry.Separately, NaCl is mixed with water, and the resulting NaCl solution isadded to the slurry in a cooking vessel. The temperature of the isomaltmixture in the cooking vessel is brought to 350° F. (about 177° C.). Ina separate vessel, nicotine solution, vanillin, sucralose, citric acid,sucralose, and additional flavoring(s) are mixed.

The isomalt mixture is allowed to cool to 300° F. (about 149° C.). Thenicotine solution-containing mixture is added to the hot isomalt mixtureand stirred for about 20 seconds or until well-blended. The resultingmixture is removed from the heat and transferred to a depositor. Arepresentative uncolored outer component mixture is set forth below.

UNCOLORED OUTER COMPONENT MIXTURE Ingredient Percent by weight IsomaltST-M 96.04 Maltitol syrup 1.00 Tobacco extract* 1.40 NaCl 1.40 Vanillin0.05 Sucralose 0.01 Citric acid 0.05 H₂O 5.00 Flavorant 0.05 *Thetobacco extract is in the form of a nicotine solution comprising 7.5%nicotine and 93.5% water.

C: Construction of Smokeless Tobacco Product

The isomalt mixtures described in Sections A and B are dispensed fromthe depositor as follows, at a temperature that allows the mixtures tomaintain some degree of flowability. From the depositor, the coloredcore component mixture is deposited into the molds first, followed bythe uncolored outer component mixture. Either a one-pass or two-passsystem can be used. In a one-pass system, both components are dispensedinto a single mold before dispensing into additional molds. The coloredcore component mixture is deposited into the mold first, followedimmediately by the uncolored outer component mixture. In a two-passsystem, a depositor containing the colored core component mixture firstdeposits the colored mixture into a series of molds; subsequently, adepositor containing the uncolored outer component mixture deposits theuncolored mixture into the molds to form the products. The smokelesstobacco products are allowed to cool and set and then dispensed from themolds. Such smokeless tobacco products are characterized by anamber-colored “dot” exposed on the surface of the product.

D: Coating of Smokeless Tobacco Product

Optionally, a coating can be applied to the smokeless tobacco productsdescribed herein, as detailed in Example 8B. Exemplary amounts ofcoating added to the products are based on the following table.

COATED TWO-COMPONENT PRODUCT Ingredient Percent by weight Uncoatedsmokeless tobacco product 99.88 CAPOL 570C 0.20

Many modifications and other embodiments of the invention will come tomind to one skilled in the art to which this invention pertains havingthe benefit of the teachings presented in the foregoing description.Therefore, it is to be understood that the invention is not to belimited to the specific embodiments disclosed and that modifications andother embodiments are intended to be included within the scope of theappended claims. Although specific terms are employed herein, they areused in a generic and descriptive sense only and not for purposes oflimitation.

What is claimed:
 1. A smokeless tobacco product comprising: a. a firstportion comprising at least about 80% by weight isomalt and a sugaralcohol syrup; and b. a second portion comprising at least about 80% byweight isomalt and a sugar alcohol syrup, wherein the two portions arevisually distinguishable by color, and wherein at least one portioncomprises a translucent tobacco extract.
 2. The smokeless tobaccoproduct of claim 1, wherein the first and second portions comprisedifferent amounts of translucent tobacco extract.
 3. The smokelesstobacco product of claim 1, wherein the first and second portionscomprise different amounts of buffer.
 4. The smokeless tobacco productof claim 1, wherein the first and second portions comprise flavorants ofdifferent types or different amounts.
 5. The smokeless tobacco productof claim 1, wherein the second portion is completely encased within thefirst portion.
 6. The smokeless tobacco product of claim 1, wherein boththe first and second portions are exposed on the surface of thesmokeless tobacco product.
 7. The smokeless tobacco product of claim 1,wherein the ratio of the first portion to the second portion is betweenabout 1:20 and about 20:1 by volume.
 8. The smokeless tobacco product ofclaim 1, wherein the ratio of the first portion to the second portion isbetween about 1:10 and about 10:1 by volume.
 9. The smokeless tobaccoproduct of claim 1, wherein the first portion comprises no addedcolorants.
 10. The smokeless tobacco product of claim 1, wherein thefirst and second portions comprise added colorants of different types ordifferent amounts.
 11. The smokeless tobacco product of claim 1,wherein: the first portion comprises isomalt, maltitol syrup, sodiumchloride, vanillin, sucralose, citric acid, a translucent tobaccoextract, and flavorant; and the second portion comprises isomalt,maltitol syrup, sodium chloride, vanillin, sucralose, citric acid, atranslucent tobacco extract, flavorant, and a colorant.
 12. Thesmokeless tobacco product of claim 1, wherein the smokeless tobaccoproduct is in the form of a lozenge with a weight of between about 1.8and about 2.2 g.
 13. The smokeless tobacco product of claim 12, whereinthe smokeless tobacco product comprises between about 0.5 mg and about 5mg nicotine.
 14. The smokeless tobacco product of claim 1, wherein theisomalt is present in an amount of at least about 90% by weight of thesmokeless tobacco product.
 15. The smokeless tobacco product of claim 1,wherein the isomalt is present in an amount of at least about 95% byweight of the smokeless tobacco product.
 16. The smokeless tobaccoproduct of claim 1, wherein one or both of the portions comprise one ormore of the following: a flavorant in an amount from about 0.05 to about15 percent by weight of the smokeless tobacco product; sucralose in theamount from about 0.01 to about 2 percent by weight of the smokelesstobacco product; and sodium chloride in the amount from about 0.5 toabout 10 percent by weight of the smokeless tobacco product.
 17. Thesmokeless tobacco product of claim 1, further comprising a throatirritation mitigant.
 18. The smokeless tobacco product of claim 1,further comprising a coating on at least a portion thereof.
 19. Thesmokeless tobacco product of claim 1, wherein one or both of the firstand second portions comprises a translucent tobacco extract in the formof an aqueous nicotine solution.
 20. A method of preparing amulticomponent smokeless tobacco product, comprising: (i) mixing isomaltand a sugar alcohol syrup to form a first mixture comprising at leastabout 80% isomalt by weight; (ii) separately mixing isomalt and a sugaralcohol syrup to form a second mixture comprising at least about 80%isomalt by weight; (iii) incorporating a translucent tobacco extractinto one or both of the first and second mixtures; (iv) combining andcooling the first and second mixtures to room temperature to form asolid smokeless tobacco product with two portions, wherein the twoportions are visually distinguishable by color.
 21. The method of claim20, wherein the translucent tobacco extract is incorporated into boththe first and second mixtures.
 22. The method of claim 20, wherein acolorant is incorporated into one of the first and second mixtures. 23.The method of claim 20, wherein a colorant is incorporated into both ofthe first and second mixtures in different amounts.
 24. The method ofclaim 20, wherein the mixing step comprises heating the isomalt to atemperature above the hard crack stage in the absence of the translucenttobacco extract, and then mixing the translucent tobacco extract intothe isomalt at a temperature below the hard crack stage.
 25. The methodof claim 24, wherein the hard crack stage is about 145° C. to about 155°C. and the isomalt is heated at a temperature between the hard crackstage and about 171° C.
 26. The method of claim 20, wherein thecombining step comprises introducing the first and second mixtures intoa plurality of molds to create individual product units prior to thecooling step.